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On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.

Erelzi® is the third etanercept biosimilar to be PBS-listed (approved November 2...

On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.  This will provide a s...

On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.

Hikma and Richter entered into...

On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL) declining Outlook’s BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet...

On 29 September 2025, Genmab A/S and Merus N.V. announced that they have entered into an agreement for Genmab to acquire all the shares of Merus in an all-cash transaction worth approximately USD 8 billion, with the deal anticipated to close early in the first quarter of 20...

On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025, offering cash-paying patients access to the drug at 55% off the list price.

According to Novartis, Cosentyx® is it...

On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in children aged six and older, weighing at least 40 ...

On 26 September 2025, Shanghai Henlius announced that the first patient has been dosed in its phase 1 multicentre clinical trial for HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).

The trial is being conducted in China to evaluate the pharmacokinetic profile, e...